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Naproxen with esomeprazole oral modified release


Modified-release formulation of naproxen and esomeprazole

Drugs List

  • naproxen with esomeprazole 500mg+20mg modified release tablet
  • VIMOVO 500mg+20mg modified release tablet
  • Therapeutic Indications


    Ankylosing spondylitis requiring ulcer prophylaxis
    Osteoarthritis requiring ulcer prophylaxis
    Rheumatoid arthritis requiring ulcer prophylaxis



    One tablet containing 500 mg naproxen and 20 mg esomeprazole twice daily.


    One tablet containing 500 mg naproxen and 20 mg esomeprazole twice daily.

    The elderly are at an increased risk of the serious consequences of adverse reactions.

    Patients with Renal Impairment

    Creatinine clearance greater than 30 ml/minute
    One tablet containing 500 mg naproxen twice daily.

    Consider a reduction in the total daily dose of naproxen.

    Patients with Hepatic Impairment

    Moderate hepatic impairment
    Consider a reduction in the total daily dose of naproxen.

    Additional Dosage Information

    A lower daily dose of naproxen should be considered for patients not previously treated with a NSAID. When a total daily dose of 1000mg naproxen is not considered appropriate, alternative therapeutic regimens should be utilised.


    Children under 18 years
    Cerebrovascular haemorrhage
    Gastrointestinal haemorrhage
    Gastrointestinal perforation
    Haematological disorder
    Peptic ulcer
    Renal impairment - creatinine clearance below 30 ml/minute
    Severe cardiac failure
    Severe hepatic impairment
    Third trimester of pregnancy

    Precautions and Warnings

    Females attempting to conceive
    Risk factors for cardiovascular disorder
    Acute porphyria
    Cerebrovascular disorder
    Congestive cardiac failure
    Connective tissue disorder
    Crohn's disease
    First trimester of pregnancy
    Hepatic impairment
    Hepato-renal syndrome
    History of gastrointestinal disorder
    History of gastrointestinal perforation
    History of gastrointestinal ulceration
    Ischaemic heart disease
    Long QT syndrome
    Peripheral arterial circulatory disorder
    Renal impairment
    Second trimester of pregnancy
    Systemic lupus erythematosus
    Ulcerative colitis

    May mask symptoms or signs of infections
    NSAIDs may provoke or exacerbate asthma
    Consider other first line treatment options in the elderly
    Exclude malignancy, if alarm symptoms develop and gastric ulcer suspected
    Contains hydroxybenzoate
    Some formulations contain propylene glycol
    Measure magnesium levels before and periodically during prolonged treatment
    Discontinue if signs of gastro-intestinal bleeding occur
    Ensure adequate vitamin D & calcium in patients at risk of osteoporosis
    If visual disturbances occur, perform ophthalmic evaluation
    May inhibit platelet aggregation - observe for signs of bleeding
    Monitor for gastrointestinal toxicity
    Monitor patients on long term therapy (over 1 year)
    Monitor renal function in patients with cardiac impairment
    Monitor renal function in patients with hepatic impairment
    Advise patient to report unexplained nausea,vomiting,abdominal pain
    Consider discontinuing if subacute cutaneous lupus erythematosus occurs
    May prolong bleeding time
    May reduce absorption of vitamin B12
    Risk of gastro-intestinal bleeding increased in the elderly
    Severe gastro-intestinal side effects may occur without warning
    May affect results of some laboratory tests
    Discontinue if severe abdominal symptoms develop
    Discontinue treatment if skin rash or other allergic reaction occurs
    Maintain treatment at the lowest effective dose
    Advise patient not to take St John's wort concurrently
    May cause impaired fertility
    Advise patient to avoid sun exposure if subacute lupus erythematosus occurs

    When a total daily dose of 1000 mg naproxen is not considered appropriate, alternative therapeutic regimens should be utilised.

    This product contains very low levels of methyl- and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

    In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with esomeprazole may alleviate symptoms and delay diagnosis.

    Treatment with proton-pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter .

    Prolonged use (greater than 1 year) of PPIs has been associated with hypomagnesaemia. Measure magnesium levels before and periodically during prolonged treatment. Patient should seek medical advice if symptoms of hypomagnesaemia occur (e.g. muscle twitches, tremors, vomiting, tiredness, loss of appetite) while taking proton pump inhibitors.

    Low serum magnesium and/or low serum potassium may result in torsades de pointes (TdP) arrhythmia and should be used with caution in Long QT Syndrome.

    Prolonged use (greater than 1 year) of PPIs has been associated with an increased risk of fracture. Ensure patients have an adequate intake of vitamin D and calcium.

    Patients on long term treatment (particularly those treated for more than a year) should be kept under regular surveillance.

    Esomeprazole may reduce the absorption of vitamin B12 due to hypo- or achlorhydria. This should be taken into consideration when treating patients with reduced body stores or risk factors of reduced vitamin B12 absorption on long-term therapy.

    Use with caution in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAIDs.

    Renal function should be assessed before and during therapy. The final pathway for elimination of naproxen metabolites is largely by urinary excretion via glomerular filtration, use with great caution in patients with impaired renal function. Monitor serum creatinine or creatinine clearance before and during therapy. A twice daily dose of 500 mg naproxen may not be appropriate and may result in the accumulation of naproxen metabolites. Continue to monitor serum creatinine or creatinine clearance levels on a regular basis in patients with the following conditions:

    The use of NSAIDs may be associated with acute renal failure in patients with severe hepato-cirrhosis. Treatment for concomitant coagulopathy could further increase the risk of severe bleeding in these patients.

    Very infrequent cases of subacute cutaneous lupus erythematosus (SCLE) have been reported in patients taking PPIs. Drug-induced SCLE can occur weeks, months or even years after exposure to the drug. The MHRA have issued the following advice if a patient treated with a PPI develops lesions - especially in sun-exposed areas of the skin - and it is accompanied by arthralgia:

    - advise them to avoid exposing the skin to sunlight
    - consider SCLE as a possible diagnosis
    - consider stopping use of the PPI unless it is imperative for a serious acid-related condition; a patient who develops SCLE with a particular PPI may be at risk of the same reaction with another
    - in most cases, symptoms resolve on PPI withdrawal; topical or systemic steroids might be necessary for treatment of SCLE only if there are no signs of remission after a few weeks or months.

    Pregnancy and Lactation


    The manufacturer contraindicates use during the third trimester of pregnancy. It should not be given to women attempting to conceive or during the first or second trimesters of pregnancy unless clearly necessary. The duration of treatment should be kept as short as possible.

    During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
    -Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension),
    -Renal dysfunction, which may progress to renal failure with oligohydramnios.
    The mother and the neonate, at the end of pregnancy, may be exposed to:
    -Possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses,
    -Inhibition of uterine contractions resulting in delayed or prolonged labour.

    If treatment during the third trimester is unavoidable, foetal circulation should be monitored with Doppler sonography and therapy discontinued at the first signs of ductal constriction.
    Naproxen should not be used during the first and second trimesters unless potential benefit outweighs the potential risk to the foetus. If short term use of an NSAID is required then ibuprofen at the recommended therapeutic doses would be the preferred choice. If an NSAID has been taken in early pregnancy Schaefer (2007) concludes that this does not require a termination of pregnancy or additional invasive diagnostic procedures.

    Animal studies with esomeprazole do not indicate direct harmful effects with respect to embryonal/foetal development. Animal studies with racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development.

    No clinical data on exposed pregnancies with the use of esomeprazole are available. As such, if a PPI is indicated, omeprazole should be used as a first choice. Inadvertent exposure in pregnancy, however, does not appear to represent a clinically significant risk to the embryo or foetus.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Naproxen and esomeprazole is contraindicated in breastfeeding.

    Although only excreted in breast milk in small quantities, naproxen has a long half life and there has been a reported serious adverse reaction in a breastfed neonate (a single case of prolonged bleeding time, haemorrhage and acute anaemia in a neonate whose mother was taking naproxen). Therefore other agents may be the preferred choice for breastfeeding women.
    If an NSAID is considered essential ibuprofen is considered the drug of choice. Levels of ibuprofen in breast milk are negligible.

    It is not known whether esomeprazole is excreted in human breast milk but the molecular weight is low enough that excretion into breast milk should be expected (Briggs). No studies in lactating women have been performed. Therefore esomeprazole should not be used during breast-feeding.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Abnormal liver function tests
    Anaphylactic reaction
    Arterial thrombosis
    Blurred vision
    Disturbances of appetite
    Dream abnormalities
    Dry mouth
    Erythema multiforme
    Exacerbation of Crohn's disease
    Fluid retention
    Gastro-intestinal ulceration
    Gastrointestinal bleeding
    Hearing disturbances
    Hypersensitivity reactions
    Increased risk of fractures
    Interstitial nephritis
    Menstrual disturbances
    Myocardial infarction
    Rectal bleeding
    Renal failure
    Serum creatinine increased
    Stevens-Johnson syndrome
    Subacute cutaneous lupus erythematosus
    Taste disturbances
    Toxic epidermal necrolysis
    Ulcerative colitis
    Weight changes

    Effects on Laboratory Tests

    It is recommended to temporarily discontinue naproxen 72 hours before Porter-Silber adrenal function test.

    Naproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).

    Esomeprazole may increase Chromogranin A (CgA) levels and may interfere with investigations for neuroendocrine tumours. To avoid this stop treatment temporarily for at least five days before CgA measurements are taken.


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: October 2013

    Reference Sources

    British National Formulary, 66th Edition (September 2013-March 2014) Pharmaceutical Press, London.

    Available at:
    Last accessed: 21 October, 2014

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Summary of Product Characteristics: Vimovo 500 mg/20 mg modified-release tablets. AstraZeneca UK Limited. Revised October 2015.

    MHRA Drug Safety Update April 2012. Proton pump inhibitors in long-term use: increased risk of fracture.
    Available at:
    Last accessed: 20 September 2015

    MHRA Drug Safety Update September 2015. Proton pump inhibitors: very low risk of subacute cutaneous lupus erythematosus.
    Available at:
    Last accessed: 20 September 2015

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Naproxen Last revised: September 7, 2013
    Last accessed: October 4, 2013

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Naproxen Last revised: September 7, 2013
    Last accessed: October 4, 2013

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